We are generating a pipeline of potential patient treatment opportunities to address chronic neurologic disorders, including levodopa-induced dyskinesia in Parkinson’s disease, multiple sclerosis, epilepsy and other indications.
ADS-5102 is a high-dose amantadine taken once daily at bedtime. ADS-5102 was designed to control the initial rate of rise in plasma concentration to mitigate the risk of central nervous system adverse events observed shortly after administration. This dosing regimen results in sustained high plasma levels of amantadine during morning and throughout waking hours when dyskinesia occurs, thereby improving the benefit-risk profile of the drug.
The New Drug Application (NDA) supporting ADS-5102 for the treatment of levodopa-induced dyskinesia in people with Parkinson’s disease is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) action date of August 24, 2017. If approved, ADS-5102 will meet a significant unmet need, as the first and only medicine approved for dyskinesia in people with Parkinson’s disease.
We are also investigating ADS-5102 for the treatment of walking impairment in multiple sclerosis patients and considering developing it for other indications in Parkinson’s disease, post-stroke walking impairment, and side effects induced by anti-psychotic drugs, such as tardive dyskinesia, akathesia and weight gain.
ADS-4101 is an investigational drug in development for the treatment of partial onset seizures in patients with epilepsy. Derived from Adamas’ development platform, ADS-4101 is a high-strength lacosamide therapy administered once daily at bedtime. Lacosamide is an anti-epilepsy active ingredient previously approved by the U.S. Food and Drug Administration and currently marketed as VIMPAT® (lacosamide). ADS-4101 is designed to deliver high concentrations of medicine during the day when seizures primarily occur and achieve higher drug levels throughout the day when we believe patients with epilepsy are most prone to seizures, with similar or better tolerability than VIMPAT.
We are currently conducting a multi-dose Phase 1b study designed to evaluate the tolerability and pharmacokinetic profile of three ascending doses of ADS-4101 administered once-daily at bedtime compared to ascending doses of twice daily VIMPAT tablets in 24 healthy volunteers. Topline data from the study is expected in the third quarter of 2017.
In our ADS-8800 series, we are developing for approval multiple fixed-dose combinations of ADS-5102, ADS-4101 and other single agents to expand the patient treatment reach associated with approved single agent medicines.